drugset / Trial / NCT07471139
SWITCH: Apixaban vs Vitamin K in HM3
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced heart failure who are chronically supported by a HeartMate 3 Left Ventricular Assist Device for 3 months.
Timeline
- Start
- 2026-06
- Primary completion
- 2029-06
- Completion
- 2029-06
Publications
- Background Netuka I, Tucanova Z, Ivak P, Gregor S, Kolesar DM, Marek T, Melenovsky V, Binova J, Dorazilova Z, Hegarova M, Podolec M, Riha H, Connors JM, Mehra MR. A Prospective Randomized Trial of Direct Oral Anticoagulant Therapy With a Fully Magnetically Levitated LVAD: The DOT-HM3 Study. Circulation. 2024 Aug 6;150(6):509-511. doi: 10.1161/CIRCULATIONAHA.124.069726. Epub 2024 Apr 9. No abstract available.
- Background Shah P, Looby M, Dimond M, Bagchi P, Shah B, Isseh I, Rollins AT, Abdul-Aziz AA, Kennedy J, Tang DG, Klein KM, Casselman S, Vermeulen C, Sheaffer W, Snipes M, Sinha SS, O'Connor CM. Evaluation of the Hemocompatibility of the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices: The DOAC LVAD Study. JACC Heart Fail. 2024 Sep;12(9):1540-1549. doi: 10.1016/j.jchf.2024.04.013. Epub 2024 May 7.